Devices

FDA Updates Safety Alert on Endovascular Graft Systems

FDA has updated its 2019 safety communication on Endologix’s AFX endovascular graft systems used in treating abdominal aortic aneurysms (AAA) and the risks associated with Type III endoleaks with the devices. It is reminding patients and health care providers of the importance of at least yearly, lifelong follow-up for all patients who have any type of Endologix AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) in order to monitor for the endoleaks.

The agency say it continues to evaluate new information which suggests the risk of Type III endoleaks may be higher than expected. “Because of ongoing concerns regarding this issue, the FDA is committed to obtaining additional postmarket data to better understand the risk of Type III endoleaks for AFX endovascular grafts,” the updated alert says. In addition, FDA will convene an advisory committee meeting in 2021 to discuss the device risks, Type III endoleak treatment options for patients who are implanted with AFX devices, and future postmarket surveillance strategies for all endovascular grafts used for treating AAA. More details will be announced in the first quarter of 2021.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome